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Found 6 results
510(k) Data Aggregation
K Number
K010447Device Name
MODIFICATION TO ACTICOAT FOAM DRESSING
Manufacturer
WESTAIM BIOMEDICAL, INC.
Date Cleared
2001-03-15
(30 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
WESTAIM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002466Device Name
ACTICOAT COMPOSITE DRESSING
Manufacturer
WESTAIM BIOMEDICAL, INC.
Date Cleared
2001-02-16
(189 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
WESTAIM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001519Device Name
ACTICOAT 7 DRESSING
Manufacturer
WESTAIM BIOMEDICAL, INC.
Date Cleared
2000-10-06
(143 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
WESTAIM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992221Device Name
ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
Manufacturer
WESTAIM BIOMEDICAL, INC.
Date Cleared
2000-06-07
(342 days)
Product Code
FRO, MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
WESTAIM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Acticoat® Primary Antimicrobial Dressing is an effective barrier to bacterial and fungal penetration. The barrier function of the dressing may help reduce infections in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, Neuropathic ulcers, diabetic ulcers, first- and second-degree burns, donor sites and surgical wounds. It may be used over debrided and grafted partial thickness wounds. It has not been evaluated in third degree burns.
Device Description
Acticoat® primary antimicrobial dressings consists of single-coated, non-adherent, high-density polyethylene (HDPE) mesh. The sustained release of silver actively protects the wound site from bacterial and fungal contamination. The dressing will be sold in a variety of sizes.
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K Number
K000051Device Name
ACTICOAT FOAM DRESSING
Manufacturer
WESTAIM BIOMEDICAL, INC.
Date Cleared
2000-04-05
(89 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
WESTAIM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983833Device Name
ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE
Manufacturer
WESTAIM BIOMEDICAL, INC.
Date Cleared
1998-12-10
(41 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
WESTAIM BIOMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Acticoat® Composite Wound Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Acticoat® dressings may be used over debrided and grafted partial thickness wounds.
Device Description
Acticoat® Composite Wound Dressing is a 3-ply dressing consisting of an absorbent rayon core with an upper layer of polyurethane film and a lower layer of silvercoated high density polyethylene mesh designed to be a barrier against microbial infections of a wound. The silver in the coating is an alloy of silver and oxygen. The coating is highly porous, and the film has enhanced solubility in water-based fluids. Additionally, the performance characteristics of the Acticoat® Composite Wound Dressing are similar to those found in untreated gauze-based dressings in the areas of absorptivity and moisture content. abrasion resistance, adhesion, and tensile strength.
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